Pre-Clinical
Regulatory Submissions

Regulatory Submissions

Ø  Development of Regulatory Strategies (pre-IND, pre-NDA)

Ø  IND/NDA and International Equivalents

Ø  IDE/510(k)/PMA and International Equivalents

Ø  Development of 505(b)(2) submissions for proprietary generics

Ø  CMC Regulatory Document Writing and Compilation

Clinical and Commercial Supply
Clinical Development
Product Development
Validation Services
cGMP and GCP Audits
International
Quality Systems